Method and device for monitoring ophthalmic lens manufacturing conditions

ABSTRACT

A method and communication system for ophthalmic device manufacturing line is disclosed. More specifically, the communication device may be incorporated in early stages of manufacturing of the ophthalmic device to monitor process controls without delay. In some embodiments, a unique pedigree profile can be stored for an ophthalmic device during manufacturing and correlated with one or more of: design profiles, controlled process parameters, performance, and distribution channels.

TECHNICAL FIELD

The disclosure generally relates to a method and a communication systemdevice used to monitor manufacturing conditions. More particularly, itrelates to the method of monitoring controlled manufacturing conditionsof an ophthalmic lens and generating an unique identifier.

BACKGROUND

Traditionally, ophthalmic devices, such as a hydrogel lens, anintraocular lens or a punctal plug, include corrective, cosmetic ortherapeutic qualities. A contact lens, for example, may provide visioncorrecting functionality, cosmetic enhancement, and/or therapeuticeffects. Each function is provided by a physical characteristic of thecontact lens. For example, a refractive quality may provide a visioncorrective function, a pigment may provide a cosmetic enhancement, andan active agent may provide a therapeutic functionality.

Ophthalmic lens manufacturing processes include, for example,sandwiching a monomer between back curve (upper) and front curve (lower)mold sections carried in a mold array. The monomer is polymerized, thusforming a lens, which is then removed from the mold sections and furthertreated in a hydration bath and packaged for consumer use. A morerecently developed manufacturing process for manufacturing high qualitycustomized ophthalmic lenses is disclosed in U.S. Pat. No. 7,905,594 toWidman, et al. which is assigned to the assignee of the presentdisclosure.

In order to reach greater design ranges and higher optical quality,currently, these and other manufacturing techniques are carried out bypartially automated and semi-automated apparatus and processes withstrict process controls and tight tolerances necessary for theproduction of high quality ophthalmic lenses. Evolving techniques employdifferent process controls seeking to improve or add a particularmanufacturing step. Examples of newly developed methodologies includenew ways of demolding the lens from the mold part, the application ofbinder layers to the mold parts, polymerization techniques, lenshydration techniques, metrology techniques, lens material development,and the such.

With new methods and lens components being developed, the complexity oftroubleshooting the desired automated process controls is sometimesgreater. In addition, because some faults may not be detected prior tothe detection of a defective ophthalmic lens during quality control,fault identification and correction can often be subject to a time delaywasting production time and materials. As a result, while theaforementioned production processes have some efficacy in the productionof soft contact lenses, they suffer a number of disadvantages which canhinder the development of a high speed automated production line capableof producing high quality ophthalmic lenses. Furthermore, with theincreasing risk of these high quality ophthalmic lenses beingcounterfeited, it is desirous for the ophthalmic lens to include acommunication system useful to provide information about the ophthalmiclens' production.

Therefore, there is a need for a communication system that can beincorporated in an ophthalmic lens and/or mold part during early stagesof manufacturing and which can be useful to generate a unique identifierwith correlated production information.

SUMMARY

Accordingly, the foregoing needs are met, to a great extent, by one ormore embodiments of the communication system. In accordance with someembodiments, the communication system includes a nano-antennaincorporated into or onto an ophthalmic device during manufacturing andis coded with an unique identifier.

According to aspects of the disclosure, a method of monitoringophthalmic lens manufacturing controlled conditions is disclosed. Themethod can comprise: placing a communication system on a lens formingsurface of a mold; energizing a communication system; storing a uniqueidentifier in the communication system; measuring a controlled conditionduring manufacturing of the ophthalmic lens using at least one or moresensor(s) in the communication system; transmitting sensor data relatingto the measured condition to a processor; and identifying a deficiencyin the controlled condition using the sensor data and the uniqueidentifier.

In some embodiments of the disclosure, an ophthalmic lens can include: ahydrogel portion supporting a communication system; the communicationsystem comprising: a processor in logical communication with one or moresensor(s) configured to measuring a controlled condition duringmanufacturing of the ophthalmic lens; a nano-antenna capable ofreceiving energy to energize the processor and the one or more sensor(s)and transmit sensor data relating to the measured controlled condition;and wherein the processor is capable of storing a unique identifier.

Certain implementations of the ophthalmic device and communicationsystem including the antenna configuration have been outlined so thatthe detailed description below may be better understood. There are, ofcourse, additional implementations that will be described below andwhich will form the subject matter of the claims.

In this respect, before explaining at least one implementation indetail, it is to be understood that the hydrogel lens including thecommunication system is not limited in its application to the details ofconstruction and to the arrangements of the components set forth in thefollowing description or illustrated in the drawings. Also, it is to beunderstood that the phraseology and terminology employed herein, as wellas in the Abstract, are for the purpose of description and should not beregarded as limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be utilized as a basisfor the designing of other structures, methods, and systems for carryingout the several purposes of the ophthalmic lens including the control,subsequent to the manufacturing of the ophthalmic lens, of dynamiccomponents that may be included in some embodiments. It is understood,therefore, that the claims include such equivalent constructions insofaras they do not depart from the spirit and scope of the presentapplication.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a cross section of a mold assembly apparatusaccording to some embodiments of the disclosure.

FIG. 2 illustrates an ophthalmic lens with a communication systemincluding an energy receptor according to some embodiments of thedisclosure.

FIG. 3 illustrates another ophthalmic lens with a media insertcomprising a communication system according to some embodiments of thedisclosure.

FIG. 4 illustrates a schematic design of a communication systemcomprising an exemplary nano-antenna according to some aspects of thedisclosure.

FIG. 5 illustrates an ophthalmic lens manufacturing apparatus that maybe used to position a communication system in a mold part for anophthalmic lens.

FIG. 6 illustrates a processor that may be used to implement someembodiments of the disclosure.

FIG. 7 illustrates method steps that may be used to generate anophthalmic lens pedigree profile during manufacturing.

FIG. 8 illustrates method steps that may be used to monitor and/ortroubleshoot manufacturing controlled conditions.

DETAILED DESCRIPTION

A communication system for an ophthalmic lens is disclosed. Thecommunication system may be used to monitor manufacturing controlledconditions and identify deficiencies in the system in a sensible manner.In some embodiments, the communication system can also be used togenerate a Lens Pedigree Profile that can be useful to ensure thecorrect ophthalmic lens reaches the consumer. For example, the LensPedigree Profile can include lens design information useful to verifythe authenticity of the ophthalmic lens.

GLOSSARY

In the description and the claims, various terms may be used for whichthe following definitions will apply:

Active Lens Insert: as used herein, may refer to an electronic orelectromechanical insert device with controls based upon logic circuits.

Communication System: as used herein, may refer to a wirelesscommunication device that can be configured to transmit and receiveelectromagnetic radiation from its components. In some embodiments, thecommunication system can include a nano-antenna, such as a nano-fractalantenna or a nano-yagi-uda type of antenna architecture, and anano-scale sensor, processor and nano-transceiver. In some preferredembodiments, the communication system can be of negligible size and bewithout consequence in most optical plastic polymer or resinapplications. In alternative embodiments, significantly opaquecomponents of larger communication systems that would impede vision maybe positioned outside of the optical zone, for example, forming part ofa Media Insert.

Energized: as used herein, may refer to the state of being able tosupply electrical current to or to have electrical energy stored within.

Energy: as used herein, may refer to the capacity of a physical systemto do work. Many uses within this disclosure may relate to the saidcapacity being able to perform electrical actions in doing work.

Energy Receptor: as used herein, may refer to a medium that canfunctions as an antenna for receiving wireless energy, such as, forexample via radio wave transmission.

Energy Source: as used herein, may refer to device or layer which iscapable of supplying Energy or placing a logical or electrical device inan Energized state.

Functionalized Layer Insert: as used herein, may refer to an insert foran ophthalmic device formed from multiple functional layers from whichat least a portion of the multiple functional layers are stacked. Themultiple layers may have unique functionality for each layer; oralternatively mixed functionality in multiple layers. In someembodiments, the layers can be rings.

Lens Design: as used herein, may refer to form, function and/orappearance of a desired Lens, which if fabricated, may providefunctional characteristics comprising but not limited to optical powercorrection, color appearance, therapeutic functionality, wearability,acceptable permeability, shape, composition, conformability, acceptablelens fit (e.g., corneal coverage and movement), and acceptable lensrotation stability.

Lens Forming Mixture: as used herein, the term “lens forming mixture” or“Reactive Mixture” or “RMM”(reactive monomer mixture) refers to amonomer or prepolymer material which can be cured and crosslinked orcrosslinked to form an Ophthalmic Lens. Various embodiments can includelens forming mixtures with one or more additives such as: UV blockers,tints, photoinitiators or catalysts, and other additives one mightdesire in an ophthalmic lenses such as, contact or intraocular lenses.

Lens Forming Surface: as used herein, may refer to a surface that isused to mold at least a portion of a lens. In some embodiments, any suchsurface, for example 103-104, can have an optical quality surfacefinish, which indicates that it is sufficiently smooth and formed sothat a lens surface fashioned by the polymerization of a lens formingmaterial in contact with the molding surface is optically acceptable.Further, in some embodiments, the lens forming surface can have ageometry that is necessary to impart to the lens surface the desiredoptical characteristics, including without limitation, spherical,aspherical and cylinder power, wave front aberration correction, cornealtopography correction and the like as well as any combinations thereof.

Media Insert: as used herein, may refer to a formable or rigid substratecapable of supporting an energization element, such as a battery, withinan ophthalmic lens. In some embodiments, the media insert also includesone or more variable optic lenses and communication systems.

Mold: as used herein, may refer to a rigid or semi-rigid object that maybe used to form lenses from uncured formulations. Some molds can includeone or more mold parts used to form a hydrogel lens comprising raisedportions.

Ocular Surface: as used herein, may refer to the anterior surface areaof the eye.

Ophthalmic Lens: as used herein, may refer to any ophthalmic device thatresides in or on the eye. These devices can provide optical correctionor may be cosmetic. For example, the term lens can refer to a contactlens, intraocular lens, overlay lens, ocular insert, optical insert orother similar device through which vision is corrected or modified, orthrough which eye physiology is cosmetically enhanced (e.g. iris color)without impeding vision. In some embodiments, the preferred lenses ofthe disclosure are soft contact lenses are made from silicone elastomersor hydrogels, which include but are not limited to silicone hydrogels,and fluorohydrogels.

Optical Zone: as used herein, may refer to an area of an ophthalmicdevice or lens through which a wearer of the ophthalmic lens sees afterthe lens is formed.

Peripheral Zone: as used herein, the term “peripheral zone” or“non-optic zone” may refer to an area of an ophthalmic lens outside ofthe optic zone of the ophthalmic lens, and therefore outside of aportion of the ophthalmic lens through which a lens wearer sees whilewearing the ophthalmic lens on, near or in the eye in a normallyprescribed fashion.

Pedigree Profile: as used herein, may refer to the background and/ormanufacturing history of an ophthalmic lens. In some preferredembodiments, the pedigree profile can include, for example, one or moreof: lens corrective specifications, base curve, material(s), encrypteddigital identification data, manufacturing facility information, andauthentication data.

Released from a Mold: as used herein, may refer to a lens that is eithercompletely separated from the mold, or is only loosely attached so thatit can be removed with mild agitation or pushed off with a swab.

Referring now to FIG. 1, a diagram of an exemplary Mold for anOphthalmic Lens with a Communication System 109 is illustrated. As usedherein, the term Mold can include a mold assembly 100 having a cavity105 into which a Lens forming mixture 110 can be dispensed such thatupon reaction or cure of the Lens Forming Mixture, an Ophthalmic Lens ofa desired shape is produced. In some embodiments, the Molds and moldassemblies 100 may be made up of more than one “mold parts” or “moldpieces” 101-102. For example, the mold parts 101-102 can be broughttogether such that a cavity 105 is formed between the mold parts 101-102in which a lens can be formed. This combination of mold parts 101-102 ispreferably temporary. Upon formation of the Ophthalmic Lens, the moldparts 101-102 can again be separated and the Ophthalmic Lens can beReleased from a Mold.

At least one mold part 101-102 has at least a portion of its LensForming Surface 103-104 in contact with the Lens Forming Mixture suchthat upon reaction or cure of the Lens Forming Mixture 110 that surface103-104 provides a desired shape and form to the portion of theOphthalmic Lens with which it is in contact. The same may be true of atleast one other mold part 101-102.

Thus, for example, in one preferred embodiment a mold assembly 100 canbe formed from two parts 101-102, a female concave piece (front piece)102 and a male convex piece (back piece) 101 with a cavity formedbetween them. The portion of the concave surface 104 which can makecontact with Lens Forming Mixture 110 has the curvature of the frontcurve of an Ophthalmic Lens to be produced in the mold assembly 100 andis sufficiently smooth and formed such that the surface of an OphthalmicLens formed by polymerization of the Lens Forming Mixture which is incontact with the concave surface 104 is optically acceptable.

In some embodiments, the front mold piece 102 can also have an annularflange integral with and surrounding circular circumferential edge 108and extends from it in a plane normal to the axis and extending from theflange (not shown).

A Lens Forming Surface can include a surface 103-104 with an opticalquality surface finish, which indicates that it is sufficiently smoothand formed so that an Ophthalmic Lens surface fashioned by thepolymerization of a Lens Forming Mixture in contact with the moldingsurface is optically acceptable. Further, in some embodiments, the LensForming Surface 103-104 can have a geometry that may be necessary toimpart to the lens surface the desired optical characteristics,including without limitation, spherical, aspherical and cylinder power,wave front aberration correction, corneal topography correction and thelike as well as any combinations thereof.

Mold part 101-102 material can include a polyolefin of one or more of:polypropylene, polystyrene, polyethylene, polymethyl methacrylate, andmodified polyolefins. A preferred alicyclic co-polymer contains twodifferent alicyclic polymers and is sold by Zeon Chemicals L.P. underthe trade name ZEONOR. There are several different grades of ZEONOR.Various grades may have glass transition temperatures ranging from 105°C. to 160° C. A specifically preferred material is ZEONOR 1060R. OtherMold materials that may be combined with one or more additives to forman Ophthalmic Lens Mold include, for example, Zieglar-Nattapolypropylene resins (sometimes referred to as znPP). On exemplaryZieglar-Natta polypropylene resin is available under the name PP 9544MED. PP 9544 MED is a clarified random copolymer for clean molding asper FDA regulation 21 CFR (c)3.2 made available by ExxonMobile ChemicalCompany. PP 9544 MED is a random copolymer (znPP) with ethylene group(hereinafter 9544 MED). Other exemplary Zieglar-Natta polypropyleneresins include: Atofina Polypropylene 3761 and Atofina Polypropylene3620WZ. Still further, in some embodiments, the Molds of the disclosuremay contain polymers such as polypropylene, polyethylene, polystyrene,polymethyl methacrylate, modified polyolefins containing an alicyclicmoiety in the main chain and cyclic polyolefins. This blend can be usedon either or more Mold parts, for example, where it is preferred thatthis blend is used on the back curve and the front curve consists of thealicyclic co-polymers.

In some preferred methods of making Molds 100, injection molding can beutilized according to known techniques, however, embodiments can alsoinclude Molds fashioned by other techniques including, for example:lathing, diamond turning, or laser cutting. Typically, lenses are formedon at least one surface of both Mold parts 101-102. However, in someembodiments, one surface of an Ophthalmic Lens may be formed from a Moldpart 101-102 and another surface of a lens can be free-formed asdescribed by other methods.

Lenses

Referring now to FIG. 2, an exemplary Ophthalmic Lens 201 is illustratedwith a Communication System 109, including a nano-antenna 401 (shown inFIG. 4) and a nano-processing device 404 (shown in FIG. 4). As shown inFIG. 4, the nano-antenna 401 can be an Energy Receptor and may be afractal nano-antenna of a conductive material, such as, a metallicmaterial. Suitable metallic materials can include, for example, gold,grapheme, silver and copper. Conductive fibers such as conductive carbonfibers can also be suitable.

The nano-antenna 401 can be in electrical communication with aprocessing device 404. The processing device 404 can include anysemiconductor type chip. In some specific embodiments, the processingdevice includes one or more nan-sensor(s) 406 (shown in FIG. 4). Theprocessing device 404 may also include multiple devices or circuitry. Inan effort to provide simplicity in this description, the one or moredevices will generally be referred to in the singular.

Referring back to FIG. 2, as illustrated, the Communication System 109can be located outside of an Optical Zone 202, wherein the Optical Zone202 includes that portion of the Ophthalmic Lens 201 providing line ofsight for a wearer of the Ophthalmic Lens 201. In some embodiments, theCommunication System 109 may be small enough to not have a significantoptical effect when it is placed in the Optical Zone 202 and itslocation may not be constrained to the Peripheral Zone.

A preferred Ophthalmic Lens type can include a Ophthalmic Lens 201 thatincludes a silicone containing component. A “silicone-containingcomponent” is one that contains at least one [—Si—O—] unit in a monomer,macromer or prepolymer. Preferably, the total Si and attached O arepresent in the silicone-containing component in an amount greater thanabout 20 weight percent, and more preferably greater than 30 weightpercent of the total molecular weight of the silicone-containingcomponent. Useful silicone-containing components preferably comprisepolymerizable functional groups such as acrylate, methacrylate,acrylamide, methacrylamide, vinyl, N-vinyl lactam, N-vinylamide, andstyryl functional groups. Suitable silicone containing componentsinclude compounds of:

where R¹ is independently selected from monovalent reactive groups,monovalent alkyl groups, or monovalent aryl groups, any of the foregoingwhich may further comprise functionality selected from hydroxy, amino,oxa, carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate,halogen or combinations thereof; and monovalent siloxane chainscomprising 1-100 Si—O repeat units which may further comprisefunctionality selected from alkyl, hydroxy, amino, oxa, carboxy, alkylcarboxy, alkoxy, amido, carbamate, halogen or combinations thereof;where b=0 to 500, where it is understood that when b is other than 0, bis a distribution having a mode equal to a stated value; wherein atleast one R¹ comprises a monovalent reactive group, and in someembodiments between one and 3 R¹ comprise monovalent reactive groups.

As used herein “monovalent reactive groups” are groups that can undergofree radical and/or cationic polymerization. Non-limiting examples offree radical reactive groups include (meth)acrylates, styryls, vinyls,vinyl ethers, C₁₋₆alkyl(meth)acrylates, (meth)acryl amides ,C₁₋₆alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,C₂₋₁₂alkenyls, C₂₋₁₂alkenylphenyls, C₂₋₁₂alkenylnaphthyls, C₂₋₆alkenylphenyl C₁₋₆ alkyls, O-vinylcarbamates and O-vinylcarbonates.Non-limiting examples of cationic reactive groups include vinyl ethersor epoxide groups and mixtures thereof. In one embodiment the freeradical reactive groups comprises (meth)acrylate, acryloxy,(meth)acrylamide, and mixtures thereof. Suitable monovalent alkyl andaryl groups include unsubstituted monovalent C₁ to C₁₆ alkyl groups,C₆-C₁₄ aryl groups, such as substituted and unsubstituted methyl, ethyl,propyl, butyl, 2-hydroxypropyl, propoxypropyl, polyethyleneoxypropyl,combinations thereof and the like.

In one embodiment b is zero, one R¹ is a monovalent reactive group, andat least 3 R¹ are selected from monovalent alkyl groups having one to 16carbon atoms, and in another embodiment from monovalent alkyl groupshaving one to 6 carbon atoms. Non-limiting examples of siliconecomponents of this embodiment include2-methyl-,2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propylester (“SiGMA”), 2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy) silane,3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”),3-methacryloxypropylbis(trimethylsiloxy)methylsilane and3-methacryloxypropylpentamethyl disiloxane.

In another embodiment, b is 2 to 20, 3 to 15 or in some embodiments 3 to10; at least one terminal R¹ comprises a monovalent reactive group andthe remaining R¹ are selected from monovalent alkyl groups having 1 to16 carbon atoms, and in another embodiment from monovalent alkyl groupshaving 1 to 6 carbon atoms. In yet another embodiment, b is 3 to 15, oneterminal R¹ comprises a monovalent reactive group, the other terminal R¹comprises a monovalent alkyl group having 1 to 6 carbon atoms and theremaining R¹ comprise monovalent alkyl group having 1 to 3 carbon atoms.Non-limiting examples of silicone components of this embodiment include(mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminatedpolydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), monomethacryloxypropylterminated mono-n-butyl terminated polydimethylsiloxanes (800-1000 MW),(“mPDMS”). In another embodiment b is 5 to 400 or from 10 to 300, bothterminal R¹ comprise monovalent reactive groups and the remaining R¹ areindependently selected from monovalent alkyl groups having 1 to 18carbon atoms which may have ether linkages between carbon atoms and mayfurther comprise halogen.

In one embodiment, where a silicone hydrogel lens is desired, the lensof the present disclosure will be made from a reactive mixturecomprising at least about 20 and preferably between about 20 and 70% wtsilicone containing components based on total weight of reactive monomercomponents from which the polymer is made. In another embodiment, one tofour R¹ comprises a vinyl carbonate or carbamate of the formula:

wherein: Y denotes O—, S— or NH—; R denotes, hydrogen or methyl; d is 1,2, 3 or 4; and q is 0 or 1.

The silicone-containing vinyl carbonate or vinyl carbamate monomersspecifically include: 1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane];3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinylcarbonate, and where biomedical devices with modulus below about 200 aredesired, only one R¹ shall comprise a monovalent reactive group and nomore than two of the remaining R¹ groups will comprise monovalentsiloxane groups.

Another class of silicone-containing components includes polyurethanemacromers of the following formulae:

(*D*A*D*G)_(α)*D*D*E¹; E(*D*G*D*A)_(α)*D*G*D*E¹ or;E(*D*A*D*G)_(α)*D*A*D*E¹   Formula IV-VI

wherein: D denotes an alkyl diradical, an alkyl cycloalkyl diradical, acycloalkyl diradical, an aryl diradical or an alkylaryl diradical having6 to 30 carbon atoms, G denotes an alkyl diradical, a cycloalkyldiradical, an alkyl cycloalkyl diradical, an aryl diradical or analkylaryl diradical having 1 to 40 carbon atoms and which may containether, thio or amine linkages in the main chain; * denotes a urethane orureido linkage; _(α) is at least 1; A denotes a divalent polymericradical of formula:

R¹¹ independently denotes an alkyl or fluoro-substituted alkyl grouphaving 1 to 10 carbon atoms which may contain ether linkages betweencarbon atoms; y is at least 1; and p provides a moiety weight of 400 to10,000; each of E and E¹ independently denotes a polymerizableunsaturated organic radical represented by formula:

wherein: R¹² is hydrogen or methyl; R¹³ is hydrogen, an alkyl radicalhaving 1 to 6 carbon atoms, or a —CO—Y—R¹⁵ radical wherein Y is —O—,Y—S—or —NH—; R¹⁴ is a divalent radical having 1 to 12 carbon atoms; Xdenotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromaticradical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or1; and z is 0 or 1. A preferred silicone-containing component is apolyurethane macromer represented by the following formula:

wherein R¹⁶ is a diradical of a diisocyanate after removal of theisocyanate group, such as the diradical of isophorone diisocyanate.Another suitable silicone containing macromer is compound of formula X(in which x+y is a number in the range of 10 to 30) formed by thereaction of fluoroether, hydroxy-terminated polydimethylsiloxane,isophorone diisocyanate and isocyanatoethylmethacrylate.

Other silicone containing components suitable for use in this disclosureinclude macromers containing polysiloxane, polyalkylene ether,diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether andpolysaccharide groups; polysiloxanes with a polar fluorinated graft orside group having a hydrogen atom attached to a terminaldifluoro-substituted carbon atom; hydrophilic siloxanyl methacrylatescontaining ether and siloxanyl linkanges and crosslinkable monomerscontaining polyether and polysiloxanyl groups. Any of the foregoingpolysiloxanes can also be used as the silicone containing component inthis disclosure.

Referring now to FIG. 3 a three dimensional cross section representationis illustrated of an exemplary Ophthalmic Lens 300 including aFunctionalized Layer Media Insert 320 configured to includeCommunication System components on one or more of its layers 330, 331,332. In the present exemplary embodiment, the Media Insert 320 surroundsthe entire periphery of the Ophthalmic Lens 300. One skilled in the artcan understand that the actual Media Insert 320 may comprise a fullannular ring or other shapes that still may reside inside or on thehydrogel portion of the Ophthalmic lens 300 and be within the size andgeometry constraints presented by the ophthalmic environment of theuser.

Layers 330, 331 and 332 are meant to illustrate three of numerous layersthat may be found in a Media Insert 320 formed as a stack of functionallayers. In some embodiments, for example, a single layer may include oneor more of: active and passive components and portions with structural,electrical or physical properties conducive to a particular purposeincluding the Communication System functions described in the presentdisclosure. Furthermore, in some embodiments, a layer 330 may include anEnergy Source, such as, one or more of: a battery, a capacitor and areceiver within the layer 330. Item 331 then, in a non-limitingexemplary sense may comprise microcircuitry in a layer that detectsactuation signals for the Ophthalmic Lens 300. In some embodiments, apower regulation layer 332, may be included that is capable of receivingpower from external sources, charges the battery layer 330 and controlsthe use of battery power from layer 330 when the Ophthalmic Lens 300 isnot in a charging environment. The power regulation may also controlsignals to an exemplary active lens, demonstrated as item 310 in thecenter annular cutout of the Media Insert 320.

An energized lens with an embedded Media Insert 320 may include anenergy source, such as an electrochemical cell or battery as the storagemeans for the energy and in some embodiments, encapsulation, andisolation of the materials comprising the energy source from anenvironment into which an Ophthalmic Lens is placed. In someembodiments, a Media Insert 320 can also include a pattern of circuitry,components, and energy sources. Various embodiments may include theMedia Insert 320 locating the pattern of circuitry, components andEnergy Sources around a periphery of an Optic Zone through which awearer of an Ophthalmic Lens would see, while other embodiments mayinclude a pattern of circuitry, components and Energy Sources which aresmall enough to not adversely affect the sight of the Ophthalmic Lenswearer and therefore the Media Insert 320 may locate them within, orexterior to, an Optical Zone.

Referring now to FIG. 4, a schematic design of the exemplaryCommunication System 109 of FIG. 1 comprising a nano-antenna 401according to some aspects of the disclosure is illustrated. In somepreferred embodiments, the nano-antenna 401 can be a fractal antennaconfigured to operate at different frequencies. The nano-antenna 401 maybe made up of a conductive material, such as, a metallic material.Suitable metallic materials can include, for example, gold, grapheme,silver and copper. Conductive fibers such as conductive carbon fiberscan also be suitable. The nano-antenna may function as an energyreceptor configured to provide a self-powered nano-Communication System109, for example, when it is exposed to a heavy radial frequency fieldabsorbing enough energy to power other electronic components. A fractalshape may include a repeating pattern or any other mathematical set thathas a dimension that usually exceeds its topological dimension. Anothertype of nano-antenna 401 can include a nano-optical Yagi-Uda antenna orthe such.

In some embodiments, the nano-antenna 401 can be in communicationnano-transceiver 402 which may be configured to perform functionsincluding baseband processing, frequency conversion, filtering and poweramplification, of the received signals transmitted into and/or out ofthe nano-antenna 401. A nano-actuator 403 may also be included in theCommunication System 109 to allow one or more nano-sensor(s) 406 tointeract with the surrounding environment. Nano-sensors can include, forexample, one or more of: physical nano-sensors capable of measuringmass, pressure, force, and/or displacement; chemical nano-sensorsconfigured to measure chemical compositions and/or concentrations; and,biological nan-sensors configured to measure antibody/antigeninteraction, DNA interaction, and/or enzymatic interactions.Nano-actuator 403 may include one or more of: physical, chemical orbiological actuators. A nano-processing device 404 comprisingnano-memory 405 in communication with the sensor 406 can function, forexample, to control the recording measured conditions by the sensor 406,execute operational sequences, generate and/or transmit data related tothe Ophthalmic Lens Pedigree Profile.

In general, according to the embodiments previously described, a MediaInsert 320 and/or self-powered nano-Communication System 109 can beembodied within or on an ophthalmic lens via automation which canplaces/deposit the components on a desired location relative to a moldpart used to fashion the Ophthalmic Lens.

Apparatus

Referring now to FIG. 5, automated apparatus 510 is illustrated with oneor transfer interfaces 511. As illustrated, multiple mold parts can eachbe associated with a mold part receptacle 514 contained within a pallet513 and presented to the transfer interface(s) 511. The transferinterface(s) 511 can place or deposit a standalone Communication System(shown in FIG. 4) or a Media Insert (shown in FIG. 3) containing theCommunication System configured to generate an Ophthalmic Lens PedigreeProfile. Embodiments can include, for example, a single interfaceindividually placing a single Communication System on a programmedmanner onto a mold part receptacle 514, or multiple interfaces (notshown) simultaneously placing multiple Communication Systems withinmultiple mold parts, and in some embodiments, within each mold part.

Another aspect of some embodiments includes apparatus to support theCommunication System while the hydrogel body of the Ophthalmic Lens ismolded around the Communication System. For example, in some embodimentsthe communication system may affix to holding points in a Mold (notillustrated). In some embodiments, the holding points may preferably beaffixed with polymerized material of the same type that will be formedinto the lens body.

Referring now to FIG. 6, a schematic diagram of a controller 600 thatmay be used with some embodiments of the present disclosure isillustrated. The controller 600 includes a processor 610, which mayinclude one or more processor components coupled to a communicationdevice 620. In some embodiments, a controller 600 can be used totransmit energy to the energy source placed in the Ophthalmic Lens.

The controller 600 can include one or more processors 610, coupled to acommunication device 620 configured to communicate logical signals via acommunication channel. The communication device 620 may be used toelectronically control one or more of: the placement of amicrocontroller and a flexible media into the Ophthalmic Lens and thetransfer of command to operate a component or the microcontroller.

The communication device 620 may also be used to communicate, forexample, with one or more controller apparatus or manufacturingequipment components.

The processor 610 is also in communication with a storage device 630.The storage device 630 may comprise any appropriate information storagedevice, including combinations of magnetic storage devices (e.g.,magnetic tape and hard disk drives), optical storage devices, and/orsemiconductor memory devices such as Random Access Memory (RAM) devicesand Read Only Memory (ROM) devices.

The storage device 630 can store a program 640 for controlling theprocessor 610. The processor 610 performs instructions of the program640, and thereby operates in accordance with the present disclosure. Forexample, the processor 610 may transmit data including, for example,unique identifier, sensor data, design information and other data thatcan be included in the Pedigree Profile. The storage device 630 can alsostore ophthalmic related data in one or more databases 650-660. Thedatabase may include customized user data, Ophthalmic Lens Pedigreeprofiles, metrology data, and specific control sequences for controllingenergy to and from the Communication System.

In some embodiments, an Ophthalmic Lens with an activation componentoperative to provide energy from an energy source incorporated into aMedia Insert.

Referring now to FIG. 7, method steps that can be used to generate anOphthalmic Lens Pedigree Profile are shown. At 701, a CommunicationSystem is energized. Energization may take place, for example, using aninternal Energy Source contained in a Media Insert and/or through anano-antenna configured to be an energy receptor and energize othercomponents of the Communication System when it is placed in a highfrequency field.

At 705, data relating to a unique identifier can be transmitted to adatabase included in one or both of a database stored in memorycontained within the Communication System and a database of an externalprocessor in communication with the Communication System. The uniqueidentifier may be a serial number that can be recorded during themanufacturing of the die and/or a numerical value assigned to a PedigreeProfile generated throughout the manufacturing of the Ophthalmic Lens710. In some preferred embodiments, the unique identifier may be storedin a database and correlated to additional information. Additionalinformation can include, for example, lens manufacturer information,customer/user data, lens design, Pedigree Profile and the like. Further,in some embodiments, the unique identifier can be encrypted and recordedin a coded signal that can be used to access said Pedigree Profile. Thecoded signal can be recorded in the Communication System and accessed byan external system, for example, on demand to protect the user byensuring the Ophthalmic Lens is not a counterfeited product. In additionto ensuring authenticity, additional information relating to theOphthalmic Lens, patient, and/or manufacturer that may be stored in adatabase and associated with the Ophthalmic Lens may be accessed.

Referring now to FIG. 8, exemplary method steps that may be used tomonitor and/or troubleshoot manufacturing controlled conditions areshown. At 801, a Communication System is placed on a Lens FormingSurface. At 805, the Communication System can be energized. At 810, aLens Forming Mixture is put in contact with the Lens Forming Surface byimmersion of the Lens Forming Mixture onto a container or depositing theLens Forming Mixture to the Mold including the Lens Forming Surface. At815, the Ophthalmic Lens can be formed according to an Ophthalmic Lensdesign using a suitable manufacturing method. Controlled conditions orprocessed during the depositing of the Lens Forming Mixture 810 and/orthe forming of the Ophthalmic Lens 815 can be monitored using one ormore sensors in communication with, and/or comprised by, theCommunication System. At 820, data relating to a controlled conditioncan be transmitted to a processor. At 825, the processor can comparepredetermined thresholds values to the transmitted data to conform tothe Ophthalmic Lens design. At 830, when the measured data is determinedto be outside the predetermined threshold, the processor may modify asubsequent process controlled condition to counteract the previousdeficiency if appropriate. At 835, the processor may categorize theOphthalmic Lens as a non-conforming one that should be discarded.

At 840, the Ophthalmic Lens may undergo quality control procedures inwhich controlled conditions may also be monitored. When anon-conformity/fault is identified, either during the manufacturing 835or the quality control process 840, the recorded data may be used toidentify the accounted process fault for the non-conformity in themanufacturing line 845. In some preferred embodiments, the processor mayadditionally send an alert to the manufacturing line operator/controllerand stop the line until further input is provided by theoperator/controller. As previously mentioned, all of the transmitteddata may be recorded in a database and used to generate the PedigreeProfile corresponding to the unique identifier stored in theCommunication System 850.

Additional features, advantages, and aspects of the disclosure may beset forth or apparent from consideration of the following detaileddescription, drawings, and claims. Moreover, it is to be understood thatboth the foregoing summary of the disclosure and the following detaileddescription are exemplary and intended to provide further explanationwithout limiting the scope of the disclosure as claimed.

What is claimed is:
 1. A method of monitoring ophthalmic lensmanufacturing controlled conditions comprising: placing a communicationsystem on a lens forming surface of a mold; energizing a communicationsystem; storing a unique identifier in the communication system of saidophthalmic lens; measuring a controlled condition during manufacturingof the ophthalmic lens using at least one or more sensor(s) in thecommunication system; transmitting sensor data relating to the measuredcondition to a processor; and identifying a deficiency in the controlledcondition using the sensor data and the unique identifier.
 2. The methodof claim 1, additionally comprising: storing thresholds according to anophthalmic lens design for a controlled condition.
 3. The method ofclaim 2, additionally comprising: modifying a manufacturing process stepwhen the measured controlled condition is outside the stored thresholdsfor the lens design.
 4. The method of claim 3, additionally comprising:sending an alert of the deficient controlled condition measured.
 5. Themethod of claim 1, wherein: the one or more sensor(s) include a physicalnano-sensor capable of measuring one or more of; mass, pressure, force,and displacement of its surroundings.
 6. The method of claim 1, wherein:the one or more sensor(s) include a chemical nano-sensor capable ofmeasuring one or both chemical composition and molecular concentration.7. The method of claim 1, wherein: the one or more sensor(s) include abiological nano-sensor capable of measuring one or more of; DNAinteraction, antibody interaction, and enzymatic interaction.
 8. Themethod of claim 1, wherein: the energization of the communication systemtakes place by placing the communication system in a heavy radialfrequency field after it is deposited in the lens forming surface. 9.The method of claim 1, wherein: the energization of the communicationsystem takes place using a battery located in a media insert.
 10. Themethod of claim 1, wherein: the sensor data forms part of a lenspedigree profile.
 11. An ophthalmic lens comprising: a hydrogel portionsupporting a communication system of said ophthalmic lens; thecommunication system of said ophthalmic lens comprising: a processor inlogical communication with one or more sensor(s) configured to measuringa controlled condition during manufacturing of the ophthalmic lens; anano-antenna capable of receiving energy to energize the processor andthe one or more sensor(s) and transmit sensor data relating to themeasured controlled condition; and wherein the processor is capable ofstoring a unique identifier.
 12. The ophthalmic lens of claim 11,wherein: the one or more sensor(s) include a physical nano-sensorcapable of measuring one or more of; mass, pressure, force, anddisplacement of its surroundings.
 13. The ophthalmic lens of claim 11,wherein: the one or more sensor(s) include a chemical nano-sensorcapable of measuring one or both chemical composition and molecularconcentration.
 14. The ophthalmic lens of claim 11, wherein: the one ormore sensor(s) include a biological nano-sensor capable of measuring oneor more of; DNA interaction, antibody interaction, and enzymaticinteraction.
 15. The ophthalmic lens of claim 11, wherein: the sensordata forms part of a lens pedigree profile.
 16. The ophthalmic lens ofclaim 11, wherein: the nano-antenna is a fractal nano-antenna.
 17. Theophthalmic lens of claim 16, wherein: the fractal nano-antenna includesa gold based composition.
 18. The ophthalmic lens of claim 16, wherein:the fractal nano-antenna includes a grapheme based composition.
 19. Theophthalmic lens of claim 11, wherein: the nano-antenna is a Yagi-Udanano-antenna.
 20. The ophthalmic lens of claim 11, wherein: the hydrogelportion of the ophthalmic lens includes a 20-70 percent silicon hydrogelcomposition.